ISRCTN ISRCTN22738539
DOI https://doi.org/10.1186/ISRCTN22738539
Secondary identifying numbers N0203125674; N0199129912; N0176115690
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
29/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr John Salmon
Scientific

John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of the effect of bleb site on eye comfort following trabeculectomy
Study objectivesTo investigate long-term post-operative eye discomfort following glaucoma surgery; in particular whether two different wound locations and therefore eye fluid drainage, differ in the level of eye comfort experienced as measured by a validated questionnaire, the 'Glaucoma Symptom Scale'.

On 14/07/2011 the following changes were made to this trial record:
1. The end date was changed from 31/12/2008 to 30/06/2010.
2. The target number of participants was changed from 40 to 150.
3. The trial was originally a multi-centre trial but due to recruitment issues at other centres the Oxford site proceeded single-handedly.
Ethics approval(s)Oxford Research Ethics Committee B, 10/09/2002, ref: C02.200
Health condition(s) or problem(s) studiedSurgery: Trabeculectomy
InterventionThe study design is a randomised trial designed to compare two accepted variations in surgical techniques of trabeculectomy and its effect on postoperative eye comfort. Patients who are undergoing first trabeculectomy will be approached to participate in the study. Patients will either be recruited in person or by invitation letter. When the patient gives written consent, they are randomised either to superior trabeculectomy or superonasal trabeculectomy. At the pre-operative visit they will answer a 10-question self-administered questionnaire, the Glaucoma Symptom Scale. Some pre-operative data will be collected on study forms identified only by hospital number and study number.

During the trabeculectomy, the bleb will be placed below the middle upper lid, or placed below the more inner upper lid.

After the trabeculectomy, usual medical care will take place uninfluenced by their participation in this study. At the 6-month post-operative visit, the patient will be examined for the study and a second Glaucoma Symptom Scale questionnaire will be completed by the patient. The examination will record clinical findings such as visual acuity, eye pressure and eye examination findings. The study ends here and patients continue their usual care.
Intervention typeProcedure/Surgery
Primary outcome measure1. Eye comfort at 6 months post-surgery as measured by the Glaucoma Symptom Scale
2. Eye features associated with eye discomfort (dysesthesia) at 6 months post-surgery
Secondary outcome measuresNo secondary outcome measures
Overall study start date10/09/2002
Completion date30/06/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants150
Key inclusion criteria1. Aged 18 years and over, either sex
2. Listed for trabeculectomy
3. Satisfy the inclusion criteria
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment10/09/2002
Date of final enrolment30/06/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter NHS Trust (UK)

No information available

Royal Berkshire and Battle Hospitals NHS Trust (UK)

No information available

Oxford Radcliffe Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan